Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia

Pain, Postoperative Clinical Trial

Official title:

Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia in Children and Adolescents After Thoracic Surgeries: a Randomized Double Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488459
• Other study ID #: 10.5
• Status: Completed
• Phase: N/A
• First received: March 22, 2018
• Last updated: April 4, 2018
• Start date: March 1, 2012
• Est. completion date: December 30, 2014

Study information

• Verified date: April 2018
• Source: National Institute for Tuberculosis and Lung Diseases, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to analyze a relationship between information support provided by an interdisciplinary team and the levels of anxiety, pain and satisfaction with postoperative analgesia in children and adolescents subjected to thoracic surgeries.

Description:

The study included 112 consecutive pediatric patients qualified for lateral thoracotomy or Ravitch procedure. The subjects were randomized to the control group (n=56) provided with a routine preoperative information from a nurse, and the experimental group (n=56) offered additional psychological consultation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 30, 2014
• Est. primary completion date: December 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

• thoracic surgery (lateral thoracotomy or Ravitch procedure),

• the American Society of Anesthesiologists score 1 or 2.

Exclusion Criteria:

• presence of a mental disorder,

• anticancer treatment,

• preoperative pain,

• problems with verbal communication ,

• lack of postoperative drainage of the chest.

Related Conditions & MeSH terms

• Pain, Postoperative
• Surgery, Thoracic

Intervention

Behavioral:
• Routine preoperative information from a nurse
Routine preoperative information from a nurse.
• Additional information support from a psychologist
Routine preoperative information from a nurse + additional information support from a psychologist.

Locations

Country	Name	City	State
Poland	Institute for Tuberculosis and Lung Diseases, Pediatric Division	Rabka-Zdrój	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
National Institute for Tuberculosis and Lung Diseases, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19. Review. — View Citation

Cuzzocrea F, Gugliandolo MC, Larcan R, Romeo C, Turiaco N, Dominici T. A psychological preoperative program: effects on anxiety and cooperative behaviors. Paediatr Anaesth. 2013 Feb;23(2):139-43. doi: 10.1111/pan.12100. — View Citation

Fincher W, Shaw J, Ramelet AS. The effectiveness of a standardised preoperative preparation in reducing child and parent anxiety: a single-blind randomised controlled trial. J Clin Nurs. 2012 Apr;21(7-8):946-55. doi: 10.1111/j.1365-2702.2011.03973.x. Epub 2012 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxiety intensity scores	Anxiety was determined with a Polish version of the self-inventory, either for children between 9 and 14 years of age, i.e. State-Trait Anxiety Inventory for Children (STAI-C; range: 20-60 pts) or for adolescents, i.e. State-Trait Anxiety Inventory (STAI; range: 20-80 pts). The instrument consisting of two separate 20-item scales measuring state and trait anxiety. In this study, the levels of anxiety were determined twice: one day prior to surgery (both trait and state anxiety) and 48 h after the procedure (only state anxiety). The results were expressed as sten scores, from 1-10 (1-4 = low level of anxiety, 5-6 = moderate level of anxiety, >7 = high level of anxiety).	day prior to surgery, postoperative day 2
Secondary	Pain intensity scores at rest	The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.	postoperative hours: 1, 2, 4, 11, 24, 48
Secondary	Pain intensity scores during deep breathing	The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.	postoperative hours: 1, 2, 4, 11, 24, 48
Secondary	Pain intensity scores during coughing	The Numeric Rating Scale (NRS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.	postoperative hours: 1, 2, 4, 11, 24, 48
Secondary	Patient satisfaction	Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good	postoperative day 2